Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants

Cocaine Dependence Clinical Trial

— Goliath  

Official title:

Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02935101
• Other study ID #: 2016-00851
• Status: Terminated
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2019
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether prednisolone lowers intensity and frequency of craving in heroin-addicted subjects undertaking a detoxification of cocaine and/or heroin.

Description:

Participants of this study are 120 heroin-addicted patients who are inward for a detoxification program for either cocaine or cocaine and heroin. Depending on the detoxification substance(s) there will be two groups of participants: Detoxification of cocaine (A; 60 participants) and detoxification of heroin and cocaine (B; 60 participants). The detoxification starts mandatory with the admission to the ward and lasts about 1-2 weeks. The participation in the study lasts about 4-5 weeks (including follow-up visits). Intake of study medication starts two days after admission and one day after informed consent. Each participant will get either 30mg/d prednisolon or placebo during five days. Participants will be under normal medical supervision during the treatment phase until follow-up 2 (final examination) provided by ward staff. Treatment days and follow-up 1 and 2 consist of : (1) vital signs (BP, HR, temperature) as measured in the daily routine, (2) at midday: visual analogue scales asking about craving for heroin and cocaine at the moment, (3) afternoon: questionnaires to survey mainly the withdrawal symptoms and vegetative parameters.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Informed Consent as documented by signature,

• age =18,

• Group A Detoxification of stimulants (cocaine, amphetamine and/or methamphetamine); ICD-10: F14.2 and/or F15.2) OR Stable opioid dependency (no parallel consumption). Detoxifica-tion of stimulants.

• Group B Opioid dependency and dependency of stimulants (cocaine, amphetamine and/or methamphetamine) and Detoxification of parallel consumption of stimulants and heroin (ICD-10: F11.2, 14.2, 15.2)

• admission for detoxification to ward U2 of the University Psychiatric Hospital of Basel

Exclusion Criteria:

• contraindications to the class of drugs under study or to any of the excipients, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;

• acute or severe co-morbid psychiatric disturbances (such as a heavy episode of major depression with suicidal ideations, acute exacerbation of a bipolar disorder, acute exacerbation of schizophrenia, alcohol addiction with an acute relapse, psychosis, dementia);

• current medical conditions excluding participation (such as acute infectious disease, moni-tored by elevated CRP, diabetes mellitus, anticoagulation therapy);

• recent history of systemic or topic glucocorticoid therapy;

• alcohol intake > 0.0 ‰ according to breathalyser test on day 0 (screening) to exclude severe alcohol abuse;

• specific drugs not allowed during the study or for specific periods of time prior to the administration of the test dose: Anticoagulant agents, antidiabetic agents, cyclosporine;

• women who are pregnant or breast feeding;

• intention to become pregnant during the course of the study;

• inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia;

• participation in another study with investigational drug within the 30 days preceding or during the present study;

• previous enrolment into the current study;

• enrolment of the investigator, his/her family members, employees and other dependent persons.

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders
• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Prednisolone
formulated for oral administration. encapsulated.
• Placebo (for Prednisolone)
Sugar pill manufactured to mimic Prednisolon 10mg capsules

Locations

Country	Name	City	State
Switzerland	Psychiatric Hospital University of Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dominique de Quervain, MD	Psychiatric Hospital of the University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heroin Craving	Heroin Craving Questionnaire, 14 items (HCQ; Tiffany et al., 1993 and Heinz et al., 2006)	Assessing change between baseline and some predefined time points during 2 weeks
Primary	Cocaine Craving	Cocaine Craving Questionnaire, 14 items (CCQ; Tiffany et al., 1993 and Heinz et al., 2006)	Assessing change between baseline and some predefined time points during 2 weeks
Primary	Heroin Craving	Visual Analogue Scale Craving	Assessing change between baseline and some predefined time points during 2 weeks
Primary	Cocaine Craving	Visual Analogue Scale Craving	Assessing change between baseline and some predefined time points during 2 weeks
Secondary	Withdrawal Symptoms according to ICD-10 (F14.3 and F12.2)		Assessing change between baseline and some predefined time points during 2 weeks
Secondary	Questionnaire 'Health State'	SF-12 (Morfeld M. et al., 2011)	Assessing change between baseline and some predefined time points during 2 weeks
Secondary	Questionnaire 'Anger/Irritation'	STAI-G form X1 (state; Laux L. et al., 1981)	Assessing change between baseline and some predefined time points during 2 weeks
Secondary	Questionnaire 'Anxiety'	STAXI (Schwenkmezger P. et al., 1992/2006)	Assessing change between baseline and some predefined time points during 2 weeks
Secondary	Saliva Cortisol levels		Assessing change between baseline and some predefined time points during 2 weeks